1. Field of the Invention
The present invention relates to a safety helmet for cranial protection. More particularly it relates to a modular helmet apparatus constructed of interchanging cooperative components of differing sizes which provide a prophylactic cushion and helmet to be worn by patients undergoing general anesthesia to prevent eye, skin, or other nerve damage from prolonged pressure upon areas of the head as well as to provide a safer manner for cranial manipulation during surgery.
2. Prior Art
Surgeries upon patients in the prone position present a number of patient care challenges to the anesthesiologist and surgical staff. Once a patient undergoing a surgery requiring general anesthesia is anesthetized, that patient is essentially in a coma like state. In such a state, noxious stimuli to the patient""s body and skin, such as pressure or pain, which would normally cause an awake patient to move to relieve the stimulus, no longer causes such a reaction. Consequently, patients under general anesthesia are especially threatened by a number of factors, other than the surgery itself, which arise during such surgical procedures.
One hazard which requires constant vigilance by the surgical staff to protect against injury is the threat of eye damage. Inadvertent pressure upon the ocular structures of a patient for just a matter of minutes can cause extreme damage or blindness to the eye. As noted above, because the anesthetized patient is in a coma like state, the discomfort of facial compression upon the eye, which would normally cause an awake patient to move and relieve that pressure, fails to alert the anesthetized patient. Care must be taken by an ever alert surgical staff to inspect for possible pressure points about the ocular structures of the patient and to move the patient""s face to prevent eye damage.
Other compression injuries can occur to the anesthetized patent""s forehead and chin areas. Here again, the constant pressure upon those areas, caused by the weight of the patients own head, if not relieved by movement of the face to allow blood flow thereto, can cause localized ischemia to the chin and forehead area. Since the anesthetized patient does not react to the body""s cues of discomfort preceding injury, the risk of harm in a matter of minutes to these areas is great.
An additional concern during surgical procedures of the anesthetized patient is the decrease in body temperature that can occur during surgery. Currently bulky warmed towels and electric blankets are used in an attempt to warm the patient. Such endeavors crowd the operating field and are not easily controlled for temperature.
Currently, there are a number of conventional methods to support the head and protect the eyes and face of a patient from compression injuries during surgery which require the patient to be placed in a prone, face down, position for the long periods of time involved in surgery. One method conventionally used is placement of the patient""s head and face in a horseshoe shaped frame supporting a foam pillow which holds the patients face off of the operating table in a supported manner. The patient""s eyes are generally taped shut when such a structure is used to keep them from contact with the foam and to prevent eye fluid drainage. This frame and pillow support however has inherent hazards of its own in that it cannot distribute pressure maximally over the surface of the head. Further, great care must be taken by the anesthesiologist and staff to make sure that any anesthetic equipment, such as endotracheal tubes, esophageal stethoscopes, or electronic sensing devices, are not dislodged or disrupted by gravity or patient positioning during the term of the surgical procedure. Such disruption or dislodgement of surgical equipment can cut off the air supply to the patient or lead to inaccurate readings by monitoring equipment.
Another method is simply to place the patient""s face sideways on a pillow or towel located upon the surgical table. However, this method suffers from the danger of tubing collapse due to the patient""s head weight, and even a face or eye supported by a foam pillow may be damaged if the pressure is uneven and remains on one area too long. Further, the placement of the patient""s face on a towel requires the head to be turned one way or the other, placing pressure on one side of the face which, as noted earlier, subjects the patient to the potential of injury. Additionally, blood flow through the veins and arteries of the neck may be impaired by this twisted fashion of head support. Hazards to the patient increase if the surgery requires a face down posture because the danger of tube collapse from pressure or bending increases with the tubes entering the patient""s body through the mouth or nose being compressed between the patient""s face and the operating table. With the entry points to the head out of view, such constrictions of the tubes also remain out of sight.
A further challenge facing surgical teams during surgery on anesthetized patients is the seemingly simple task of rolling the patient over from a supine position to a prone position on the operating table or from a cart onto the operating table. Generally, the patient at this point in the surgical procedure is already intubated, asleep, and basically xe2x80x9cdead weight.xe2x80x9d In this physical state, the patient is at great risk of injury during the roll over procedure, especially to the neck area. Additionally vexing to the surgical staff is the fact that the patient, with tubes exiting the mouth and/or nose, must be rolled over, without disturbing the tubes and without injuring the neck. Concurrently during the roll over procedure, the surgical staff must plan ahead so that when the patient is placed face down on an operating table, the face is properly aligned with, and inserted upon or into the pillow, already located upon the table. This insertion of the face into the pillow is conventionally done without the benefit of a pre surgery fit to make sure the face and pillow and frame mate in a manner that will accommodate the patient for the term of the surgery and protect the face from compression injury. Heads and faces being quite different amongst people in general, an optimum fit between face and pillow is achieved only a small percentage of the time. Once in this prone position, the danger of injury remains constant and continued and consistent vigilance by the surgical staff is required to ascertain, that in fact, the patient""s airways are open, the eyes are not compressed, and the face is not being subjected to pressure at any point for a duration sufficient to cause nerve damage.
Finally, when the operation is over, the patient must again be moved off of the operating table and is generally rolled over onto a gurney in a reverse roll over procedure. Still anesthetized, the patient is at great risk of injury to the neck if the head is not adequately supported and manipulated during this roll over process.
Still further, if an emergency develops while the patient is in the face down prone position, requiring the patient to be rolled to the supine position, valuable life saving time can be lost trying to upright the patient without injury to the neck, and without crimping the airway supply tubing and monitoring equipment communicating through the nose and mouth of the patient.
Further, patient size is also a factor in the fitting of facial and head support. A child may have a very small face and head and an adult a large one. Conversely, a large child may have a head and face requiring support in areas much different from a small stature adult.
U.S. Pat. No. 5,220,699 (Farris) teaches an inflatable pillow mounted inside a mask for variable support of differing sized patients. However Farris requires the use of an inflatable chamber which as taught is inflated once the patient has already been rolled to the prone position. It requires an air inflation device to function and lacks the ability for an easy installation prior to surgery and will not function without compressed air.
U.S. Pat. No. 4,400,820 (O""Dell) teaches an apparatus using pads and having a xe2x80x9cTxe2x80x9d shaped void which may be used in combination with a support structure to hold the patient""s head. However, O""Dell does not allow for pre-fitting and pre-installing the protective device prior to surgery and does not aid in protecting the patient during roll over on and off the table.
U.S. Pat. No. 5,214,815 (Agbodoe) teaches a surgical headrest with a removable foam pad; however, Agbodoe does not provide any manner to pre-fit and install the device on the patient prior to being asleep and it mounts to the table and is intended for use after roll over thereon.
U.S. Pat. No. 4,757,983 (Ray) features a pair of cushions attached to a horseshoe-shaped frame for surgical head support. However Ray also suffers from an inability to pre-fit and install the device on patients prior to surgery while they are awake as well as lacking any protective ability during dangerous roll over onto the table and like the aforementioned prior art, lacks the ability to see the patient""s eyes and face from the side or from above.
As such, there exists a need for a support device that is easily modified to fit a variety of patients of differing size, and that may be pre-fit to the patient prior to surgery while the patient is alert and able to ascertain the comfort or discomfort level of the device. Further such a device should provide an additional manner to support the head and maximally diffuse pressure over a large area while helping prevent patient thermal heat loss during surgery, as well as during the hazardous movement of the patient prior to and after surgery. Such a device should also provide for easy viewing of the patient""s eyes and nose from a side and top view during the operative procedure so that the patient may be continually monitored by the staff.
A further need exists for such a device that may be cooperatively engaged with a positionable mount or used by itself if needed yet still provide a view of the eyes and ocular area of the patient from looking inward from the side.
The present invention relates to a new and improved protective helmet apparatus which provided functionally through the ability to vary the configuration for the physical characteristics of patients undergoing general anesthesia during surgery, and provide optimum cranial support to the patent using differing configurations of the various parts of the device. Concurrently, the device, when using a substantially transparent helmet casing and operatively placed apertures provides the medical professionals operating on the patient, easy viewing of the patients facial features and easy access to the nasal and oral passages of the patient in either the prone or supine position. The device is best made of modular construction allowing for the substantially transparent helmet casing to fit a variety of different sized patients. Interchangeable and replaceable cushions of variable dimensions on one surface to accommodate different patient facial structures are positionaable in a plurality of interchangeable light weight helmet casings. The cushions on their exterior surface are dimensioned for a registered fit with the helmet casing surface and apertures in the cushion register with apertures in the helmet casing. The cushions can also be color coded to designate different sizes to accommodate different sized patients. If desired, while not the best mode for maximum support and positioning, the cushions themselves can be used without the helmet casing, yet still provide a side view of the patient""s eyes and temple area during the procedure through an aperture communicating through a sidewall to the face of the patient. Such might be the case in emergencies when sufficient helmet casings are not available or when a low mount of the patient""s head is desirable.
The device is especially useful in that it allows for pre-fitting of the patient while the patient is awake and alert using modular pads of differing facial dimensions and having a rear or mask side dimension configured to fit into a registered position in the helmet casing. While the current best mode combines the proper sized cushion with the appropriate helmet casing for a mount on the table surface, even using the facial cushion by itself, if desired, yields a substantial increase in utility over prior art due to the viewing of the patient""s eyes and temple area from the side afforded by the apertures therefor. The device having the pre-fitted cushions or pads mounted into the helmet casing, and featuring appropriate indentations on the facial contact surface, evenly diffuses pressures on the face of the wearer and may be worn into surgery such that the surgical team need not worry about trying to fit the patient with pillows or pads in a table mounted frames after the patient is asleep.
For use in a variety of patients in prone or supine positions during surgery the various embodiments of the device offer a plurality of ways in which to support the patient""s head. One embodiment features a hinged or optionally removable lower chin support which is moveable from a first position in operable contact with the helmet casing to a second position out of such contact, thus allowing the surgical team easy access to the entire face and mouth area for insertion of required tubing into the patients mouth and/or nose. The chin support is thereafter reinstalled to provide lower chin support with the entire helmet being worn by the patient for the rollover procedure on and off the table to protect the patient from injury during the course of the surgical procedure. Or, the chin support may be provided by the cushion itself with the cushion and the helmet casing extending below the mouth area of the patient thus eliminating the detachable chin support.
As the device may be pre-fitted for optimal weight diffusion and comfort and can be worn during the movement of the patient on and off the operating table, the surgical team is relieved on concerns of whether the device to hold the face and head actually fits the patient. Further, an optional rotating handle upon the top of the helmet provides a handy gripping point for the head for the surgical team to help prevent neck injury during roll over of the patient on and off the table. By placement of a hand on the face of the mask and another on the rotating handle, smooth and continual support may be provided to the neck and head area when the patient is being rolled over on or off of the operating table.
Another embodiment of the device features a helmet casing, which is best made of substantially transparent material, having an interior cavity that is formed to register with a cooperatively engageable cushion. The cushion is made from foam or other soft resilient material and is dimensioned on one surface to accommodate the patient""s face, and on the other opposite or exterior surface, to register with the interior cavity of the helmet casing. A raised border about the exterior surface perimeter of the cushion could be formed during manufacture to provide an additional means to register and align the cushion with the openings in the helmet casing. Optionally, the cushions may be color coded for patient facial sizing. One or a plurality of apertures communicating through the helmet casing register with appropriately configured apertures communicating between the two surfaces of the cushion and provide an in line cavity from the patient""s face through the casing. This in-line cavity provides access to the patient""s mouth, nose, and eyes. By dimensioning the cavity to extend around the patients face at eye level, easy viewing of the patient""s eyes and nose is provided to the operating room staff.
An additional embodiment of the device would feature a plurality of legs on the exterior surface of the helmet casing to provide a raised mount above the operating table. The legs can be adjustable for height above the operating table to provide comfortable posture to the patient while affording the best access and view of the face of the patient to the staff of the operating room.
In the current best mode, an optional base may also be provided which provides a releasable but solid mount for the helmet casing using cooperating fasteners located on the mount and the exterior of the helmet casing. The mount acts as a positioner by providing a stable mount for the helmet casing and optionally may provide additional utility in the best mode with a surface mounted mirror for providing a reflective view of the patient""s eyes and nose to the staff of the operating room while the patient is face down and the staff is substantially in an upright position. This eliminates the constant need for members of the operating team to bend over to inspect the face and eyes of the patient during surgery in providing a continuous view of the eyes and face of the face-down patient. Additional utility is provided by an optional light means positioned on the upper surface of the mount adjacent to the mirror by illuminating the patient""s face through the in-line cavity and enlightening the reflection on the mirror for the staff to more easily view it from a distance.
An object of this invention is to provide a helmet which prevents injury due to ocular compression during surgery by minimizing ischemic damages through maximal diffusion of pressure about the patient""s head.
Another object of this invention is the provision of a protective device for use during surgery which allows for pre-fit of the patient prior to surgery while the patient may comment on the comfort or discomfort level of the device.
A further object of this invention is to provide a protective helmet for surgery which provides a facial and chin support to the patient which is easily removable by the surgical team for insertion of required devices into the mouth and nose of patient and thereafter easily reinstalled.
An additional object of this invention is the allowance of easy access to and viewing of, the patients eyes and temple area through apertures in the device positioned to accommodate such access and viewing.
Another object of this invention is the provision of a protective surgical helmet of modular construction which allows for positioning of different sized facial cushions and components into the helmet casing to accommodate the head different sized patients.
An additional object of this invention is providing an easily sterilized protective helmet through the use of easily sterilized cushions or inexpensive throw away insertable cushions removably mountable inside an easily sterilized or cleaned helmet shell.
A still further object of this invention is to concurrently provide easy viewing of the eyes and mouth area of the patient while the device is mounted upon the patient.
A still further object of the invention is the provision of the ability to control and alter the temperature of the device to aid in temperature control of the patient during surgery.
An additional object of this invention is to provide easy viewing of the patients facial features to the operating staff using while concurrently allows the staff members to remain substantially upright through the provision of a reflective means of the face of the patient.
Further objects of the invention will be brought out in the following part of the specification, wherein detailed description is for the purpose of fully disclosing the invention without placing limitations thereon.